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The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)

21. července 2026 aktualizováno: AstraZeneca
Given the high variability in the inflammatory profiles of CRSwNP (Chronic rhinosinusitis with nasal polyps) patients that influence both disease phenotype and response to treatment, exploring further potential targets is crucial for advancing novel biologic treatment strategies. By indicating the efficacy of targeted therapy, as well as determining clinical features, endotyping of CRSwNP may offer a useful tool to better tailor treatment approaches in this heterogenous patient population. This study is the first national effort to collect data on inflammatory markers and burden of CRSwNP patients in Greece aiming at identifying disease endotypes based on patients' inflammatory profile.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights. Patients who discontinue should be asked about the reason(s) for their discontinuation. If the participant withdraws consent for disclosure of future information, AstraZeneca may retain and continue to use any data collected before such a withdrawal of consent

Typ studie

Pozorovací

Zápis (Odhadovaný)

230

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Řecko
      • Alexandroupoli, Řecko
        • Nábor
        • Research Site
      • Athens, Řecko
        • Zatím nenabíráme
        • Research Site
      • Heraklion, Řecko
        • Zatím nenabíráme
        • Research Site
      • Thessaloniki, Řecko
        • Zatím nenabíráme
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

CRSwNP patients who are scheduled to undergo first ESS (prospective patients) will be recruited from approximately 6 Ear-Nose-Throat (ENT) and 1 pulmonology clinics. Moreover, CRSwNP and CRSsNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples (retrospective patients) will be recruited from 1 ENT clinic.

Popis

Inclusion Criteria:

  • Age ≥ 18 years
  • If CRSwNP group:

Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:

  • CRSwNP severity consistent with the need for surgery as defined by a total nasal polyp score (NPS) of ≥5 (≥2 for each nostril)
  • Nasal Congestion Score (NCS) of ≥2
  • Ongoing documented symptoms of CRSwNP for > 8 weeks before surgery

If CRSsNP group:

Diagnosis of CRSsNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines

  • Have performed in the period between 2012 and enrolment or are scheduled to perform endoscopic sinus surgery (ESS) for the first time at enrolment
  • Have available nasal polyp tissue sample from the first endoscopic sinus surgery (ESS)
  • Have provided signed and dated written informed consent
  • If CRSwNP group:

Patients receiving any standard of care treatment for CRSwNP, provided the participant is stable on that treatment for ≥30 days

Exclusion Criteria:

  • Patients with cystic fibrosis or immunodeficiency
  • Presence of acute exacerbation of CRS symptoms within 2 weeks prior to surgery
  • Use of systemic corticosteroids within 30 days prior to surgery, or antileukotrienes within 15 days prior to surgery, or biologic therapy prior to surgery
  • Not adequate amount (<0.15g) or quality (e.g. storage temperature, contamination) of tissue sample for analyses
  • Not available blood (serum) sample, only for patients scheduled to perform endoscopic sinus surgery (ESS) for the first time at the date of enrolment, for analyses.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Prospective (CRSwNP)
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
Jiný: Not applicable - NIS study
Not applicable - NIS study
Retrospective (CRSwNP)
CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
Jiný: Not applicable - NIS study
Not applicable - NIS study
Retrospective (CRSsNP)
CRSsNP (Chronic rhinosinusitis without nasal polyps) patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
Jiný: Not applicable - NIS study
Not applicable - NIS study

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
At Visit 1 (day 1)
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
At Visit 1 (day 1)
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Eosinophil and neutrophil cell counts will be recorded, as per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf.
At Visit 1 (day 1)
Characterization of nasal histological alterations in retrospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Tissue morphology and potential tissue destruction and nasal epithelium remodeling by standard histology staining (e.g. hematoxylin and eosin, Periodic Acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
At Visit 1 (day 1)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Časové okno: Up to 24 ± 2 months (through study completion)
Demographics at study entry/screening (age, sex, ethnicity, smoking status, cigarettes/day/year, alcohol status (units/week), body measurements (BMI kg/m2), employment status, educational level, residence area) will be recorded
Up to 24 ± 2 months (through study completion)
1i. Description of medical history of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Časové okno: Up to 24 ± 2 months (through study completion)
Patients' medical history, including the date of first and severe CRSwNP diagnosis, comorbidities, and disease management [use (yes/no) of saline, systemic/local glucocorticoids, biologics, antibiotics], will be reported at the time of enrolment and during 24 months after first ESS.
Up to 24 ± 2 months (through study completion)
1i. Description of first ESS characteristics in CRSwNP patients
Časové okno: At Visit 1 (day 1)
Time to first ESS from CRSwNP diagnosis and from severe CRSwNP diagnosis will be assessed
At Visit 1 (day 1)
1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
Časové okno: Up to 24 ± 2 months (through study completion)
The 22-item Sinonasal Outcome Test (SNOT-22), which is a health-related quality of life (HRQoL) evaluation with each item scored on a Likert scale ranging from 0 "No problem" to 5 "Problem as bad as it can be".
Up to 24 ± 2 months (through study completion)
1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
Časové okno: Up to 24 ± 2 months (through study completion)
The Nasal Polyposis Symptom Diary (NPSD), which is a short patient-reported outcome (PRO) tool comprising 11 items (8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance). The Total Symptom Score (TSS) is a summary of the first 8 symptom-specific items, scored on a 4-point scale [0-none, 1-mild, 2-moderate, 3-severe], with a resulting score from 0 to 24
Up to 24 ± 2 months (through study completion)
1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma)
Časové okno: Up to 24 ± 2 months (through study completion)
The Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma that includes 5 items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The ACT responses for each of the items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
Up to 24 ± 2 months (through study completion)
1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
Časové okno: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
NPS is a physician-reported tool that grades the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 - "No nasal polyps" to 4 - "Large nasal polyps causing complete obstruction of the inferior nasal cavity", with the total score being the sum of left and right nostril scores (range: 0-8).
Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
1iii. Assessment of imaging results in CRSwNP patients
Časové okno: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
The Lund-Mackay (LM) CT score that evaluates sinus opacification on CT scans. This score ranges from 0 -"complete lucency of all sinuses" to 24 - "complete opacity of all sinuses"
Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
2. Characterization of blood cytokines/chemokines in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Cytokine/chemokine analysis of blood samples following first ESS will be performed by Luminex and ELISA analysis
At Visit 1 (day 1)
2. Characterization of blood immune cell populations in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
At Visit 1 (day 1)
2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Serum immunoglobulin levels [total IgE, specific IgE to staphylococcal enterotoxins (SE-IgE)]
At Visit 1 (day 1)
2. Characterization of WBC count in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
Differential WBC count (incl. absolute count) will be recorded
At Visit 1 (day 1)
2. Characterization of RBC count in prospective patients with CRSwNP
Časové okno: At Visit 1 (day 1)
RBC count will be recorded
At Visit 1 (day 1)
3. Association of time to CRSwNP recurrence and CRSwNP endotypes over 24 months following first ESS in CRSwNP patients
Časové okno: Up to 24 ± 2 months (through study completion)
The number of CRSwNP recurrences along with the date(s) of recurrence(s) will be recorded in the eCRF by the investigator at 24 months following first ESS for CRSwNP patients (including retrospective CRSwNP patients, if data are available). The time to relapse during the 24-month follow-up will be also estimated.
Up to 24 ± 2 months (through study completion)
4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
Časové okno: At Visit 1 (day 1)
Endotypes of CRSsNP patients who have performed first ESS in the period between 2012 and enrolment (retrospective patients) will be determined based on cytokine/chemokine analysis of frozen extracted nasal tissue from ESS, including Fractalkine, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, (p70), IL-13, IL-17A, IL-21, IL-23, ITAC, MIP-1α, MIP-1β, MIP-3α, TNF-α, TSLP, IL-9, IL-33, IL-17E/IL-25, TGFb1, IL-22
At Visit 1 (day 1)
4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
Časové okno: At Visit 1 (day 1)
Eosinophil and neutrophil cell counts will be recorded. As per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf
At Visit 1 (day 1)
4. Differences in nasal tissue alterations between retrospective patients with CRSwNP and CRSsNP
Časové okno: At Visit 1 (day 1)
tissue morphology and potential nasal tissue destruction and remodeling by standard histology staining (e.g. Hematoxylin and eosin, Periodic acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks. Depending on the nature of tissue pathology, further immunohistochemical analysis will be performed with the use of specific antibodies, such as markers for epithelial barrier integrity (e.g. E-cadherin or Cytokeratin), tissue remodeling (e.g. MMP-9) or chronic damage monitored by fibrosis (e.g. α-SMA or collagen)
At Visit 1 (day 1)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AstraZeneca

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

29. června 2026

Primární dokončení (Odhadovaný)

31. prosince 2029

Dokončení studie (Odhadovaný)

31. prosince 2029

Termíny zápisu do studia

První předloženo

18. května 2026

První předloženo, které splnilo kritéria kontroly kvality

17. června 2026

První zveřejněno (Aktuální)

23. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • D5242R00007

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Časový rámec sdílení IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kritéria přístupu pro sdílení IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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